Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication | FDA

The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit. Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performanceContinue…

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First Covid-19 ART kit developed and made in S’pore approved for sale | The Straits Times

SINGAPORE – The first antigen rapid test (ART) kits for Covid-19 to be developed and manufactured in Singapore have been approved for retail sale by the Health Sciences Authority (HSA) under the Pandemic Special Access Route.Local diagnostics and reagents company Cellbae, which developed the self-test kit, said it decided to establish research and manufacturing in Singapore to better serve people here and in the region after the major supply chain disruption caused by the pandemic.CalledContinue…

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